The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0860-2023·Announced 2023-06-07

Prescription eye solution recalled due to discontinued stability studies

Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recalls with hospitalization reports warrant severity of 4, but this recall reports no illnesses or injuries. The hazard is a manufacturing practice deviation affecting stability verification—a risk-of-harm product without confirmed harm, warranting severity of 3.

Plain-English summary

Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% distributed nationwide in the USA and Puerto Rico.

The FDA classified this as a Class II recall due to a Current Good Manufacturing Practice (CGMP) deviation. Akorn, Inc. ceased business operations and can no longer conduct the stability studies required to verify the product remains safe and effective throughout its shelf life.

The recalled product

Product
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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